Methods, systems, and apparatuses for delivery of electrolysis products

ABSTRACT

Example apparatuses and systems are disclosed for providing controlled delivery of electrolysis products to a site which may be used for treatment of infection and ablation of undesirable cells and tissue. A system disclosed may include a power supply, two electrodes, an aqueous matrix that may close the electric circuit between the electrodes at the treated site, and a controller. The controller may control the electrical circuit to induce a direct current through the electrodes and an aqueous matrix to produce electrolysis products. The duration and magnitude of the charge applied may determine the dose of the products applied to the treatment site. The composition of the electrodes and the aqueous matrix may be chosen to produce desired products. An apparatus is disclosed that may be in the form of a pad for applying to a wound. An apparatus is disclosed that may be used for treating internal tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 16/219,815, filed on Dec. 13, 2018, which is a continuation of U.S.application Ser. No. 15/036,386, filed May 12, 2016 and issued as U.S.Pat. No. 10,154,873, on Dec. 18, 2018, which is a national stageapplication of PCT Application No. PCT/US2014/065783, filed Nov. 14,2014, which claims priority to provisional applications U.S. Ser. No.61/904,142 filed on Nov. 14, 2013, U.S. Ser. No. 61/921,084 filed onDec. 27, 2013, and U.S. Ser. No. 61/938,623 filed on Feb. 11, 2014.

The entire disclosures of the afore-mentioned applications areconsidered to be part of the disclosure of the instant application andare hereby incorporated by reference in their entirety for any purpose.

BACKGROUND

Electrolysis generally refers to a process of inducing anelectrochemical reaction that involves passing a direct current throughan ionic solution via electrodes. Electrolysis may facilitate theremoval and/or addition of electrons from atoms and/or ions, which maylead to the formation of new products. For example, by passing a DCcurrent through a saline solution (NaCl and H₂O), hypochlorous acid(HClO) may be formed.

Hypochlorous acid has disinfecting properties and is often used as acleaning agent. In some applications, hypochlorous acid is used toablate unwanted tissue and/or disinfect wounds in tissue. Hypochlorousacid is typically introduced to the wound by pouring a solution ofhypochlorous acid over the wound or soaking a wound dressing inhypochlorous acid and applying the dressing to the wound.

When exposed to air, hypochlorous acid decomposes over time. As the acidbreaks down, the disinfecting and ablation properties are decreased. Tomaintain effectiveness, fresh hypochlorous acid is poured over the woundand/or the soaked gauze is replaced at multiple intervals. The laborintensive nature of continuingly treating wounds to ensure effectivenessof disinfection as well as the lack of precision in delivering thehypochlorous acid may make this mode of use of hypochlorous acidimpractical in emergency and clinical environments.

SUMMARY

An example apparatus for delivery of electrolysis products to a siteaccording to an embodiment of the disclosure may include an electrode,an aqueous matrix in contact with the electrode, wherein the aqueousmatrix may include a saline solution, wherein the electrode may includea material and the aqueous matrix may have a pH, the material and the pHmay be selected to produce the electrolysis products when a current ispassed through the aqueous matrix using the electrode, and wherein theelectrode and the aqueous matrix may be packaged for placement proximatethe site.

An example system for delivery of electrolysis products to a site mayinclude a device which may be positioned proximate the site, wherein thedevice may include an electrode and an aqueous matrix, a power supply, acontroller which may be positioned at the site or remotely from thesite, the controller may be in communication with the electricalcircuit, and wherein the controller may be programmed to provide anelectronic signal to the circuit for the electrode to produce theelectrolysis products, wherein the electronic signal may be indicativeof a dose of the electrolysis products and the timing of the productionof the dose.

An example method for delivering electrolysis products to a site mayinclude using a controller remote from the site, generating anelectrical signal indicative of a timing and dose of the electrolysisproducts, providing the electrical signal to a device proximate thesite, wherein the device is configured to generate the electrolysisproducts responsive to the electrical signal.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present disclosure will becomemore fully apparent from the following description and appended claims,taken in conjunction with the accompanying drawings. Understanding thatthese drawings depict only several examples in accordance with thedisclosure and are, therefore, not to be considered limiting of itsscope, the disclosure will be described with additional specificity anddetail through use of the accompanying drawings, in which

FIG. 1 is a schematic illustration of the electrical circuit accordingto an embodiment of the disclosure.

FIG. 2 is a schematic illustration of an apparatus for delivery ofelectrolysis products to a site according to an embodiment of thedisclosure.

FIG. 3 is a schematic illustration of an arrangement of electrodesaccording to an embodiment of the disclosure.

FIG. 4 is a schematic illustration of another arrangement of electrodesaccording to an embodiment of the disclosure.

FIG. 5 is a schematic illustration of a system for producingelectrolysis products for the treatment of surface of tissue accordingto an embodiment of the disclosure.

FIG. 6 is a schematic illustration of an internal electrolysis apparatusaccording to an embodiment of the disclosure.

FIG. 7 is a schematic illustration of an internal electrolysis apparatusaccording to an embodiment of the disclosure.

FIG. 8 is a schematic illustration of an internal electrolysis apparatusaccording to an embodiment of the disclosure.

FIG. 9 is a schematic illustration of an internal electrolysis apparatusaccording to an embodiment of the disclosure.

FIG. 10 is a schematic illustration of a pad in accordance with anembodiment of the disclosure.

DETAILED DESCRIPTION

Certain details are set forth below to provide a sufficientunderstanding of embodiments of the disclosure. However, it will beclear to one skilled in the art that embodiments of the disclosure maybe practiced without these particular details. Moreover, the particularembodiments of the present disclosure described herein are provided byway of example and should not be used to limit the scope of theinvention to these particular embodiments. In other instances,well-known materials, components, processes, controller components,software, circuitry, timing diagrams, and/or anatomy have not beendescribed or shown in detail in order to avoid unnecessarily obscuringthe embodiments.

In some embodiments, electrolysis products, such as hypochlorous acid,may be used for disinfecting and/or ablation. The products may beproduced and delivered in a controlled manner to maintain effectiveness.In some embodiments, a system and/or apparatus may include a solutioncapable of producing, upon electrolysis, sterilizing products. Thesolution may be brought into contact with the tissue to be treated.Electrodes capable of producing electrolysis may be brought into contactwith the solution, and an electric current may be generated in thesolution that produces the desired levels of electrolysis products. Themagnitude and duration of the current generated may be controlled tomodulate the amount of products produced.

FIG. 1 is a schematic illustration of the electrical circuit 1000 whichmay be used to deliver electrolysis products according to an embodimentof the disclosure. The electrical circuit may include a power supply1005, two or more electrodes 1010, 1015 coupled to the power supply1005, and a control system 1020 that may regulate the current and/orvoltage through the circuit 1000 or portions thereof. The electricalcircuit 1000 may be closed at least in part through an aqueous matrix1025. The design of the circuit may be such that the current is forcedto pass at least in part through the aqueous matrix 1025. The aqueousmatrix 1025 may include a manmade material, a biological material, or acombination thereof. The aqueous matrix 1025 may be at a treatment sitein direct contact or part of the treatment site. The aqueous matrix 1025may be the site at which products of electrolysis are generated. Thecontroller 1020 may turn on and of the power to the circuit 1000, mayadjust the level of power delivered, and may operate the circuit 1000 inconjunction with other devices. Optionally, the controller 1020 mayreceive feedback from measurements made in the aqueous matrix 1025 by asensor 1030. The controller 1020 may also optionally receive signalsfrom an external controller 1035.

FIG. 2 is a schematic illustration of an apparatus for delivery ofelectrolysis products to a site according to an embodiment of thedisclosure. The apparatus 200 may include at least one electrode and anaqueous matrix in contract with the electrode. Generally, the electrodeand the aqueous matrix may be selected such that electrolysis productsare produced in the aqueous matrix when a current is passed through theaqueous matrix using the electrode. The aqueous matrix may include amanmade material such as a hydrogel and/or a biological material such astissue. The electrode and aqueous matrix may be packaged for placementproximate the site to which delivery of electrolysis products isdesired. In FIG. 2, an electrode 210 and aqueous matrix 225 are shownpackaged in a pad 200.

At least one electrode may be included in the apparatus. The electrode210 is shown in FIG. 2, and may be a cathode in some embodiments. Insome examples, however, the electrode 210 may be placed at a locationremote from the apparatus, such as proximate another location of apatient's body in some examples. A second electrode may be included inthe apparatus, such as the electrode 220 shown in FIG. 2. In someexamples, the electrode 220 may be an anode.

Electrode materials are generally selected to include a material that isselected to produce the electrolysis products when a current is passedthrough the aqueous matrix using the electrode. The materials chosen forthe electrodes, including the electrodes 210, 220, may be chosen toproduce certain the electrolysis products. For example, an anode (e.g.electrode 220) may include iridium oxide and/or rubidium oxide depositedon titanium, which may improve the production of hypochlorous acid, anda cathode (e.g. electrode 210) may include copper. The use of mixedmetal oxide anode electrodes may produce different species ofelectrolytic products that may be tailored for different clinical needs.The electrodes may also include different materials with properties ofinterest. For example, platinum may be used if inert electrodes aredesired or silver electrodes or silver/silver chloride electrodes ifsilver ions are desired in the solution, which may further enhance thesterilization effect.

In the example shown in FIG. 2, the electrodes 210 and 220 are separatedby an insulating layer 215. The insulating layer 215 may be implementedusing any suitable insulating material. In some embodiments, theinsulating layer 215 between the electrodes 210, 220 may be omitted. Insome embodiments, a portion of the aqueous matrix 225 is between theelectrodes 210, 220. In some embodiments, a portion of the aqueousmatrix 225 is between the electrode 210 and the impermeable barrier 205.

One or more of the electrodes in the apparatus, such as the electrodes210 and/or 220 may be externally-accessible for receipt of an electronicsignal from a controller, which may be placed remotely from theapparatus, such as the apparatus 200. In some embodiments, thecontroller may be integrated with apparatus 200.

Apparatuses described herein may include an aqueous matrix in contractwith at least one electrode. The aqueous matrix 225 is shown in FIG. 2in contact with both the electrodes 210, 220. Aqueous matrices describedherein, including the aqueous matrix 225, may include components forforming electrolysis products. In some embodiments, the aqueous matrix225 may be implemented using a gel and/or hydrogel. The aqueous matrixmay include a saline solution. The aqueous matrix may have a pH selectedto produce electrolysis products, such as hypochlorous acid. In someexamples, the pH of the aqueous matrix 225 may range between 2 and 5.The aqueous matrix 225 may be placed in contact with a site for deliveryof electrolysis products, such as by laying a pad including the aqueousmatrix 225 on the site.

In some embodiments, the aqueous matrix 225 may include a low pH salinesolution (e.g. about 3 to 4 pH) that is configured for the production ofhypochlorous acid. The materials included in the solution included inthe aqueous matrix 225 may be chosen to produce the desired electrolysisproducts, such as hypochlorous acid). In some embodiments, the aqueousmatrix 225 may have a higher electrical conductivity than the site fordelivery of electrolysis products. The higher electrical conductivity ofthe aqueous matrix 225 may result in electrolysis products producedprimarily in the aqueous matrix 225, not the tissue at the site. Theionic composition of the aqueous matrix 225 may be designed to have thedesired conductivity but to include different ions from those normallyin tissue, for example a greater concentration of Na or Ca. In someembodiments, the aqueous matrix 225 may be infused with a drug forcombination therapy at the treatment site. That is, both the drug andelectrolysis products are delivered to the treatment site.

In some embodiments, aqueous matrices described herein, such as theaqueous matrix 225, may be implemented using a liquid solution. Theliquid solution may be prepared separately and applied directly to thetreatment site before placement of the impermeable barrier 205. In someembodiments, the treatment pad 200 may be placed at the treatment siteand the aqueous matrix 225 may be introduced to the treatment site byinjecting it through a port (not shown) in the impermeable barrier 205.In some embodiments, the treatment pad 200 includes a dehydrated gel.Before use, the gel may be hydrated with a solution, such as saline, toform the aqueous matrix 225. In some embodiments, the aqueous matrix 225is already present in the treatment pad 200. In some embodiments theaqueous matrix is combined with body tissue and/or body fluids.

In some embodiments, the at least one electrode in the apparatus may becoupled to a power supply. For example, the electrodes 210, 220 in FIG.1 may be coupled to a power supply (not shown). Examples of powersupplies may include, but are not limited to, one or more batteries, acomputer (e.g., coupled via USB cable), a cellular phone, a regulatedpower supply that draws energy from the electrical network, a solarcell, and combinations thereof. The power supply may be incorporated inthe apparatus, e.g. the treatment pad 200. The power supply generallyprovides power to one or more electrodes to power the electrolysisprocess.

The electrode and aqueous matrix may be packaged for placement proximatea site of delivery for the electrolysis products. For example, theelectrode and aqueous matrix may be packaged into the pad 200 shown inFIG. 2. In some embodiments, some or all of the components of the pad200 are disposable. In some embodiments, some or all of the componentsof the pad 200 are sterilizable. In some embodiments, some or all of thecomponents of the pad 200 may be multi-use.

In some embodiments, the pad 200 is sized to cover a large area of asite. In some embodiments, the pad 200 may have smaller dimensions tolimit delivery of electrolysis products to a smaller area. The pad 200may be implemented in a variety of shapes. For example, the pad 200 maybe square, rectangular, circular, ovular, half-moon. Other shapes mayalso be possible. The shape and/or size of the pad 200 may be selectedbased on the size and/or shape of the site for delivery.

The pad 200 may include an impermeable barrier 205 which may include aperiphery (not shown) that may extend beyond the dimensions of theelectrodes 210, 220 and/or aqueous matrix 225. The periphery of theimpermeable barrier 205 may include an adhesive that may be used tosecure the pad 200 to the site. In some embodiments, the pad 200 issecured by bandages. In some embodiments, the pad 200 is not secured tothe treatment site.

While shown packaged as a pad 200 in FIG. 2, a pad may not be used insome examples. In some embodiments, an aqueous matrix may be applied toa site and electrodes applied to the aqueous matrix. For example, it maybe desired to treat a confined space between two tissues or inside ofone tissue (e.g., a needle hole). The aqueous matrix may be introducedinto the confined space, and the electrodes may be inserted into orproximate the confined space. The electrodes may be coupled to acontroller and/or low voltage source outside the confined space.

In some examples, ablation by electrolysis may be performed in theinterior of a blood vessel or a cavity inside the body. In someembodiments, electrodes may touch a tissue of interest and an ionic flowthat propagates by diffusion may be directed towards the tissue ofinterest. In some embodiments, the flow of ions in an undesirabledirection may be impeded by impermeable surfaces. In some embodiments,the direction of flow of ions may be controlled through the use ofiontophoresis, electro osmosis and/or electrophoresis.

Example sites include wounds. Examples of wounds that may be treatedinclude but are not limited to bed sores, diabetic ulcers, burns, tears,gashes, surgical incisions, cuts, scrapes, irradiation and scarsformation. The pad 200 may accordingly be configured to adhere to thewound. In some embodiments, the apparatuses described herein, such aspad 200, may be used for cosmetic procedures. For example, unwantedcosmetic features may be ablated or the electrolysis products may inducetightening of the skin. Example sites include infected tissue, acne,and/or the pad may be configured for placement on an implantable device(e.g. pacemaker, joint implant, or other medical device). Whenactivated, the pad can then be used to treat an infection proximate theimplanted device.

Other example sites for delivery of electrolysis products include amalignant tumor, an abdomen surface, a nerve, a benign tumor, a bloodvessel surface, an intestinal surface, an esophagus surface, a urethrasurface, a bladder surface, or combinations thereof.

Example apparatuses described herein, such as the pad 200 of FIG. 2, maybe packaged for placement proximate a site for delivery of electrolysisproducts. In this manner, the device may be placed locally to the sitefor delivery such that the electrolysis products generated by theapparatus may diffuse into and/or be driven toward the site. Forexample, during operation, the electrodes 210,220 shown in FIG. 2 may becoupled to a power supply, such as a battery. While the pad 200 isapplied to the site, the electrodes 210,220 may be energized by powersupply, and electrolysis products are formed in the aqueous matrix 225.The electrolysis products may diffuse into the site for an amount oftime. A controller (not shown in FIG. 2) may control the coupling of theelectrodes 210, 220 to the power supply. The controller may modulate theconnection between the electrodes 210, 220 to the power supply to turnon and off current in the aqueous matrix 225, thereby controllinggeneration of electrolysis products.

In some embodiments, the electrolytic reaction induces a flow ofmaterial through the aqueous matrix 225. The flow may extend furtherinto the treatment site. The iontophoretic, electro-osmotic and/orelectrophoretic flow may enhance transport of the electrolysis productsinto the treatment site. This may allow deeper tissue to be treated bythe treatment pad 200. In some embodiments, a negative pressure source(not shown) may be used in conjunction with the treatment pad 200 andmay be applied to the tissue treated by the treatment pad 200. Thenegative pressure source may be a tube coupled to a vacuum, a hypobariccompartment, or a manual suction bulb. Other negative pressure sourcesmay be used. The negative pressure source may further enhance productionof the electrolysis products at the treatment site and/or removedepleted products and/or ablated materials. In some embodiments, thenegative pressure source is manually operated by a user. In someembodiments, the negative pressure source is operated by the controller.

FIG. 3 is a schematic illustration of an alternative arrangement ofelectrodes 300 according to an embodiment of the disclosure. In thisarrangement, electrodes 305, 310 may be formed in the same horizontalplane and may be separated by an aqueous matrix 315. In someembodiments, the aqueous matrix 315 may be replaced by a non-conductingfilm on which the electrodes 305, 315 are sputtered. The film may beembedded in or placed on or in an aqueous matrix.

FIG. 4 is a schematic illustration of an alternative arrangement ofelectrodes 400 according to an embodiment of the disclosure. In thisarrangement, an anode 410 is disk-shaped and mounted to a disk-shapecathode 405. As shown in FIG. 4, the cathode 405 has a diameter greaterthan the diameter of the anode 410, however, in some embodiments, theanode 410 may have a diameter greater than the cathode 405. The cathode405 and anode 410 may have an insulation layer coupled between them (notshown) in some embodiments. In some embodiments, the electrodes 400 areembedded in or placed on an aqueous matrix.

FIGS. 1-4 show various electrode configurations for performingelectrolysis. However, these configurations are exemplary, and thedisclosure is not limited to these particular electrode configurationsand additional electrode configurations may be used. For example, needleelectrodes, wire electrodes, and/or surface electrodes may be used.Needle electrodes may, for example, penetrate a tissue to whichelectrolysis products may be delivered. Surface electrodes may be placedon or near a surface of a tissue to which electrolysis products may bedelivered. For example, surface pad electrodes may be used whereelectrodes are packaged in a pad which is placed proximate (e.g. on)tissue to be treated.

FIG. 5 is a schematic illustration of a system 100 for producingelectrolysis products (e.g. electrolytic product), which may be used todeliver electrolysis products to a site, for example for the treatmentof a tissue surface according to an embodiment of the disclosure. A pad105, which may be implemented using the pad 200 of FIG. 2, may beproximate a site that is to be treated (e.g. tissue 10). The pad may becoupled to a power supply 115. An electrical circuit may be implementedthrough the pad and/or tissue using the circuit in FIG. 1 in someexamples. The production and delivery of electrolysis products to thetissue 10 by the pad 105 may be controlled by a controller 110. Thecontroller 110 may, for example, be programmed to provide an electronicsignal to the pad 105 and/or power supply 115. The electronic signal maybe indicative of a dose of electrolysis products. For example, theelectronic signal may control the timing and magnitude of a currentgenerated in the pad 105 to produce electrolysis products. This mayallow a user to customize treatment of the tissue 10. For example, thecontroller 110 may transmit an electronic signal to the pad 105 and/orthe power supply 115 to cause the pad 105 to produce a particular flow(e.g. constant flow) of electrolysis products to the tissue 10. In thismanner, a controller may be used to electronically control thegeneration and application of electrolysis products to a site, where thesite is proximal an example pad as described herein. Although shown asseparate components coupled to the treatment pad 105, in someembodiments, the controller 110 and/or the power supply 115 may beintegrated into the treatment pad 105. In some embodiments, thecontroller 110 may include a programmable chip coupled to the treatmentpad 105 and/or power supply 115. In some embodiments, the controller 110may be implemented using a computing device (not shown) and be remotelycoupled to the treatment pad 105. The computing device may beimplemented using, for example a desktop, laptop, server, handhelddevice, a personal computer, a tablet computer, and/or a smart phone. Insome examples, the computing device may be integrated with and/or sharedwith another piece of medical equipment, such as an injection pump, anegative pressure system, or combinations thereof. In some examples, thecontroller may be programmed to provide an electronic signal indicativeof electrolysis product dose and also control the other piece of medicalequipment. The controller 110 may be coupled by a wire or communicatewith the treatment pad 105 and/or the power supply 115 wirelessly.

The controller may be programmed to provide an electronic signalindicative of a dose of the electrolysis products to an electrodedescribed herein. The controller may, for example, include such aprogram, or include one or more processing devices (e.g. processors)coupled to a memory encoded with executable instructions forelectrolysis product delivery. The controller may cause the currentthrough the electrodes to be pulsed. Other modulation patterns may alsobe used. The controller may also control the voltage of the power supplyin some embodiments. Treatment dosage may also be adjusted by themagnitude of the current applied and duration of energy applied to theaqueous matrix of apparatuses described herein. In some examples, lengthand/or magnitude of the electronic signal may further indicate a desireddepth of the electrolysis product delivery. Generally, a longerapplication of a current may cause electrolysis products to be producedfor a longer time, allowing them to diffuse deeper into the site.

The system 100 may further include a sensor (not shown) for measurementof pH near at least one electrode in the apparatus for delivery ofelectrolysis products, such as the pad 105. The sensor may sense pH nearthe electrode and provide the pH value to the controller, such as thecontroller 110. The controller 110 may further be programmed to adjustan electronic signal provided to the pad 105 and/or power supply 115based on the pH near the electrode. If the pH varies outside of apredetermined range, additional components may be added to the aqueousmatrix to adjust the pH to return it to a range desired for producingthe electrolysis products.

FIG. 6 is a schematic illustration of an internal electrolysis apparatusaccording to an embodiment of the disclosure. A balloon catheter 500 mayinclude an electrode 505 deposited or attached to an outer balloonsurface 510. The catheter 500 may include a multi lumen shaft 515 thatmay allow for inflation/deflation of the balloon 510, and one or moreelectrodes 505 to be coupled via conductors to a power source and/orcontroller. In some embodiments, the multi-lumen shaft 515 may includeone or more fluid transfer lumens 520. In some embodiments the ballooncatheter 500 may be inserted or in contact with an aqueous matrix 530around the electrode 505. The aqueous matrix 530 may include a manmadematerial, a biological material, or a combination thereof. In someembodiments one or more electrodes may be a remote needle or pad 525,inserted or in contact with a tissue or with the aqueous matrix 530. Theaqueous matrix may include a manmade material, a biological material, ora combination thereof. In some embodiments, the fluid transfer lumen 520may deliver and/or remove fluid substances proximate the electrodes 505.For example, a fluid transfer lumen 520 may deliver a saline solution tothe electrodes 505 which may increase the production of hypochlorousacid proximate the target site. In some embodiments, the fluid transferlumen 520 may remove depleted solution, degraded electrolysis products,and/or ablated tissue from the target site. The addition and/or removalof fluids from the target site may allow for adjustments to theproperties of the solution such as pH, ionic composition, and/or dosage.In some embodiments, the removed fluids may be collected and analyzed.For example, the pH of the removed solution may be determined. The pH ofthe removed solution may determine the composition of new solutiondelivered to the target site. In another example, the solution may beanalyzed for the presence of living microorganisms to determine theeffectiveness of a sterilization procedure. Other analysis of theremoved solution may also be performed.

In some embodiments, the balloon 510 may prevent the flow of ions fromthe aqueous matrix 530 in an undesirable direction. This may allow fordiffusion of electrolysis products from the aqueous matrix 530 into avessel wall or other target tissue, causing ablation on the targetedregion. In some embodiments, multiple balloons 510 may be included inthe catheter 500. The balloons 510 may isolate a target tissue fortreatment, which may allow for controlled diffusion of electrolysisproducts from the aqueous matrix 530 into the target tissue. In someembodiments, the balloon 510 may be ring-shaped. That is, the balloon510 may include a channel near the middle portion which may allow atleast partial flow of fluid through the balloon 510. This may allow theelectrodes 505 to contact the target site for electrolysis, but allowfor blood flow and/or other fluid flow during treatment.

In some embodiments, the electrode 505 may be deposited on themulti-lumen shaft 515 in addition to on the balloon 510. In someembodiments, the electrode 505 may be deposited on the multi-lumen shaft515 instead of on the balloon 510. The electrode 505 may be deposited onthe multi-lumen shaft 515 upstream and/or downstream from the balloon510. In some embodiments, when two balloons 510 are included in thecatheter 500, the electrode 505 may be deposited on the multi-lumenshaft 515 between the two balloons 510. Other electrode 505 locationsmay be used.

FIG. 7 is a schematic illustration of another internal electrolysisapparatus 600 according to an embodiment of the disclosure. Theapparatus may include a spring electrode 605 design with an impermeablesurface 610 attached to the back of the electrodes 605. The springelectrode 605 with the impermeable surface 610 may be embedded in anaqueous matrix 620. The aqueous matrix 620 may include a manmadematerial, a biological material, or a combination thereof. Theimpermeable surface 610 may allow for controlled diffusion ofelectrolysis products from the aqueous matrix 620 into the targettissue. The spring electrodes 605 may be a variety of different shapesand polarities. In some embodiments, the center shaft 615 mayincorporate one polarity while the outer spring electrodes 605 are thesame polarity and opposite polarity of the center shaft 615. In someembodiments, the apparatus 600 may allow for the application ofelectrolysis without occluding a vessel, duct, and/or passage.

FIG. 8 is a schematic illustration of another internal electrolysisapparatus 700 according to an embodiment of the disclosure. Theapparatus 700 may include a stent 705 embedded in an aqueous matrix 715.The aqueous matrix 715 may include a manmade material, a biologicalmaterial, or a combination thereof. The stent 705 may have one or moreconfigurations. In some embodiments, the stent 705 may act as anelectrode. For example, a wire mesh stent may be used to deliver a lowvoltage direct current to the tissue. In some embodiments, inner wall ofthe stent 705 may be coated on one side with the aqueous matrix 715 andon the other side with an impermeable surface which may direct diffusionof electrolysis products from the aqueous matrix 715 into a target site,such as a vessel wall. In some embodiments, the stent 705 may be anitinol stent that may have the inner surface of the stent 705 coated ina similar fashion. The stent 705 may be configured as either a monopolarelectrodes with a shaft 710 as a return, or with a remote secondelectrode as illustrated in FIG. 6 in a bipolar configuration with bothpolarities built into the stent 705 but separated by a non-conductingsurface. In some embodiments, the impermeable surface may act as anon-conductor to separate the two conducting surfaces on the stent 705.

FIG. 9 is a schematic illustration of another internal electrolysisapparatus 800 according to an embodiment of the disclosure. Theapparatus 800 may include a solid insert 805 a portion of which is atleast one electrode 810. In some examples, the electrode 810 is ananode. The electrode 810, which may be an anode, may be surrounded by anaqueous matrix 820. The aqueous matrix 820 may include a manmadematerial, a biological material, or a combination thereof. In someexamples, the insert 805 is a needle. A second electrode 815 may bepositioned on the surface of the insert 805 and/or in an aqueous matrixsurrounding the insert. In some embodiments, the one or more electrodesmay be mounted on the outer surface of the insert. The outer surface ofthe insert 805 may be electrically insulated except for the surface areaof the electrodes 810, 815. The apparatus 800 may be directly introducedto the treatment site under imaging (CT. MR, Ultrasound) guidance. Anelectrical circuit including at least two electrodes and the aqueousmatrix 820 may be coupled to a power source (not shown). The powersource may be outside the body or inside the body. The power source maybe a battery. The power source may be a constant DC current powersupply. The treatment may be controlled by a microprocessor (not shown)to determine and deliver dose specific treatment parameters to thetargeted treatment site. A treatment planning system may be used tocalculate optimal treatment zone placement over the targeted treatmentareas to guide placement of the insert electrode.

The internal electrolysis apparatuses illustrated in FIGS. 6-9 mayinclude imaging components. This may allow real time monitoring ofelectrolysis treatment.

The internal electrolysis apparatuses described above may be used inmultiple applications. Examples of applications include targeted lungdenervation for chronic obstructive pulmonary disease, renaldenervation, and carotid body receptors for congestive heart failure.Another application may involve the use of a balloon catheter withelectrodes in the treatment of percutaneous trans luminal coronaryangioplasty (PTCA). In this application, an apparatus, for example theapparatus 500, may be used for a traditional angioplasty procedure. Theelectrodes incorporated on the balloon surface may then be activated preor post balloon dilation to treat the vessel walls through theproduction of hypochlorous acid, which may reduce the rate ofrestenosis. The intraluminal electrolysis allows for treatment of thesmooth muscle below the surface which may inhibit the formation of aneointima.

In another application for treatment of restenosis, an apparatus, suchas the apparatus in FIG. 8 may be applied to combine the use of a stentwith the treatment of intraluminal electrolysis. In this approach, thestent may be placed by conventional means. Intraluminal electrolysis maybe applied via the stent which may prohibit restenosis. The intraluminalelectrolysis may allow for treatment of the smooth muscle below thesurface which may inhibit formation of a neointima.

In another clinical application, intraluminal electrolysis may be usedto treat Deep Vein Thrombosis (DVT). An apparatus such as apparatus 500,may be used to combine a catheter based procedure with the treatment oftransluminal electrolysis. In this approach, the catheter may bepositioned in a normal fashion to dilate the restricted vessel. Beforeor after dilation, intraluminal electrolysis may be applied, to producehypochlorous acid to treat the remaining clotted area as well as thesurfaces below the vessel wall which may prevent recurrence. The lowthermal aspects of the intraluminal electrolysis may make itparticularly attractive for this type of application, because of thereduced or non-existent swelling of the tissue as a result of thethermal damage.

In another application for the treatment of DVT, an apparatus, such asapparatus 700 may be used to combine a stent with the treatment of theintraluminal electrolysis. In this approach, the stent may be place in anormal fashion. Intraluminal electrolysis may be applied via the stentin order to treat any remaining clotted area as well as below thesurface which may prevent recurrence.

In another clinical application, intraluminal electrolysis may be usedto treat Peripheral Artery Disease (PAD). An apparatus such as apparatus500 may be used to combine a balloon catheter with intraluminalelectrolysis. In this approach, the balloon may be placed byconventional means. Intraluminal electrolysis may be applied via theelectrodes mounted on the balloon which may treat any remaining plaqueas well as the surfaces below the vessel wall which may preventrecurrence.

In another application for PAD, an apparatus such as the apparatus 700may be used to combine a stent with the treatment of intraluminalelectrolysis. In this approach the stent may be placed in normalfashion. Intraluminal electrolysis may be applied via the stent to treatany remaining plaque as well as the surfaces below the vessel wall whichmay prevent recurrence.

Addition clinical applications of intraluminal electrolysis may includeablation of malignant and benign cell growth on the inner surface of theesophagus (Barrett Syndrome), colon—tumors, rectal tumors, tumors in themouth, opening of veins for treatment of varicose veins. Intraluminalelectrolysis can be utilized inside the heart for ablation proceduresthat require full transmural lesions. The clinical applicationsdiscussed above are exemplary and should not be construed to limit thedisclosure to the listed applications.

Some specific experimental examples are provided below to facilitateappreciation of embodiments described herein. The experimental examplespresented are not intended to be comprehensive or exhaustive of allexperiments performed or of all results obtained.

Example I

In a first non-limiting example, two electrodes of an electrolysistreatment system are configured similar to the electrodes in FIG. 3. Theanode is a 1.5-inch (39.4 mm) diameter circle of Titanium, grade 2. Itis 0.0005 inches (0.010 mm) thick. The Ti was submersed in iridiumchloride and then place in an oven at 450 C for 2 hours. The iridiumchloride reacts with the oxygen at high temperatures and a layer ofIridium oxide develops on the titanium and this serves as the anode inour system. An Iridium oxide electrode was used here because it servesas a catalyst to the production of HClO. There may be other materialsthat catalyze the production of HClO, such as Ruthenium Oxide.

The larger circle with circumferential holes is made of Pyralux(Dupont). It has an outer diameter of 2 inches (53 mm) and a copperlayer of 35 microns coated on one side with a high dielectric plastic of45 micron. The copper surface serves as a cathode. Other materials canbe used for cathodes such as Carbon, graphite, graphene, Ag/AgCl. Theanode and cathode are attached across the plastic layer, which is usedto electrically separate the anode from the cathode. Eight holes of adiameter of 0.085 inches (2.1 mm) are equally spaced at a diameter of0.2 inches (6.8 mm) The holes serve an important function, as a conduitfor the transport of ions between the cathode and anode, which may begenerally referred to as a salt bridge. A path for ion transport may berequired for the system to function. Two strips extend from the anodeand cathode for the purpose of connecting the electrodes to the powersupply and the power delivery control system.

The electrodes are then embedded in a gel in the Petri dish. The gel is0.7 gr. UltraPure Agarose (Invitrogen Cat No. 155510-027) dissolved in100 ml of distilled water. To maintain a pH of ˜4, 590 ml of 1 MolarCitric Acid and 410 ml of Sodium Citrat was introduced. To maintain aphysiological saline composition, 9 gr of NaCl were mixed into thesolution. The solution was cast in a 2″ diameter, Petri dish that servedas a mold, in such a way that the electrode assembly was in the middleof the cast. The thickness of the gel is 6 mm.

Wires were coupled to the anode and cathode of the electrode unit. Thewires leaving the electrode unit are connected to an Agilent E3631Aconstant current power supply. A top gel layer of a Methyl Violet(Fluka) dye infused agar gel, was set on top of the electrolysis gel inwhich the electrode unit was embedded to serve as a measurement markerfor the production of hypochlorous acid. The thickness of themeasurement marker gel is 7 mm and the diameter is 2 inch. Methyl Violetis denatured by hypochlorous acid and turns clear. As hypochlorous acidis produced at the anode and diffuses into the Methyl Violet dye gellayer, the gel becomes clear where the HClO has interacted with theMethyl Violet. The bottom gel is a pH sensitive dye infused agar. Thethickness of the gel is 7 mm and the diameter is 2 inch (53 mm).Whenever a basic or acid solution interacts with the dye a color changeoccurs. Hydroxides produced at the cathode, turn this gel into a bluecolor.

A voltage of 4 V, (98+/−8 mA) was applied for 10 minutes across theelectrodes. Knowing the time and the charge delivered, as well as the pHof the gel, allows a calculation of the amount of free chlorine producedby this system. In this case, It was calculated that approximately 35 mgof free chlorine was produced over the 10 min period. The ability tocalculate the electrolysis products may facilitates a precisequantitative and temporal delivery of the disinfection species. Chlorinegas bubbles may form on the anode. These bubbles may be trapped in thegel of the pad, between the anode and the gel. Because they are trappedand the chlorine produced species diffuse away into the treatmenttarget, the amount produced during these 10 minutes of operation may becompletely utilized, which may facilitate precise quantitative deliveryof hypochlorous acid. In contrast, in systems that employ HClO solutionsin the form of a fluid open to the atmosphere, the active compounds canevaporate and dissipate. After 10 min of activation, hypochlorous acidinduced denaturation of the methyl violet dye at the interface betweenthe electrolytic gel and the Methyl Violet stained gel. The copper onthe back oxidized, but continued to work. There was no leakage, and verylittle hydroxide was produced. To avoid this oxidation, the cathodecould be made of other materials such as carbon.

Following 10 minutes of activation the current was stopped and theelectrolytic pad was allowed to remain in place for another 30 minutes.After 40 minutes of application, of which only 10 minutes were active,the penetration of HClO and the discoloration is much larger that afterthe 10 minutes of activation. The gel pad may trap all the electrolysisproducts in the gel pad assembly. After 10 minutes activation all theproducts are still in the gel. The pH of 4 of the gel may assure thatthe products are primarily hypochlorous acid. The gel continues tosupply the precise quantity of hypochlorous acid embedded in the gel.Thirty minutes after the electric activation of the pad has stopped, thehypochlorous acid continues to penetrate the methyl sample. However theamount delivered may be precise.

There was little change in the pH dye gel facing the cathode. Except insome corners that may have been a result of leakage from the anode side.This indicates that this particular design favors the production of HClOat the anode, facing the treatment site.

Another experiment with the Methyl violet test pad with another designconfiguration. In this design configuration the gel pad with theelectrodes was kept in the Petri dish, allowing only the anode side tobe in contact with the test pad. The cathode side was in contact withthe Petri dish wall. In this experiment the electrodes were activatedfor 20 minutes with a voltage of 4V and a current of 118 mA, for acalculated total of 70 mg free chlorine. The treated pad becametransparent. The electrolysis device produced complete saturation of thetreated pad, throughout the treated pad after 20 minutes of activation.

Example II

In a second non-limiting example, experiments employed a large 6″ (153mm) Petri dish. A hole with a diameter of 3.5″ (88 mm) was cut throughthe back of the Petri dish, to allow access to the precisionelectrolysis pad and to negative controls. The precision electrolysispad was placed inside the hole. In this design the cathode side wascovered with an impermeable coating. The two electrodes of the pad wereconnected to an Agilent E3631A constant current power supply.

The large 6 inch (153 mm) Petri dish was filled with physiological agar(1 gram tryptone, 0.5 g yeast, 0.9 g NaCl, 1.5 g Agar per 100 mL) toallow growth of E. coli of an antibiotic resistant strain, ATCC 55244.The height of the gel, from the bottom of the Petri dish was 5 mm. Thehole in the back of the Petri dish allowed contact with the active(anode) side of the electrolysis pad and to the negative controls of: a)Gauze saturated with Anasept (HClO containing fluid), b) Allevyn—silverdressing, c) Procellera wound pad (self-powered galvanic systemgenerating Ag and Zn ions). The electrolysis pad anode side, was placedflush with the inner surface of the Petri dish, in good contact with thegel.

A positive control was also prepared. The Petri dish had a 5 mm highagar gel as described earlier. As in all the experiments, a thin layerof E. coli ATCC 55244 was spread on the top of the gel, on the surfaceopposite to the surface in contact with the bottom surface of the Petridish. The control was left outside on the bench at room temperature for50 minutes, similar to the protocols in which active sterilization wasattempted. It was then placed overnight, for 18 hours, in an incubatorat 37 C.

In the electrolysis experiments, the electrode pad was placed asdescribed previously. As in all these experiments, a thin layer of E.coli was spread on the top agar plates surface. Electrolysis wasgenerated by passing a voltage of 4 Volts (approximate current was 50-60milliAmps) through the electrodes for 20 minutes. Then the electrolysispad was left in situ for 30 more minutes. Following the experiments allplates were collected and placed in an incubator overnight for 18 hoursat 37 C. A region in which there was no E. coli growth formed inrelation to the hole at the bottom of the Petri dish where theelectrolysis pad was present. It was evident that the sterilization ofthe bacteria occurred within the outline of the anode on the pad. Thepad was placed on the back side of a surface contaminated with E. coli.The distance between the pad and the contaminated surface was 5 mm. Thissuggests the electrolysis pad may have the ability to sterilize deep inthe body.

A first negative control study was performed by using in the sameexperimental configuration with a gauze saturated with a commercial HClOproduct (Anasept). The pad was placed on the part of the gel with thehole, in a similar way to the placement of the precision electrolysispad. The use was according to the manufacturer recommendations. Similarto the previous experiments, the E. coli was spread on the surface ofthe gel opposite the placement of the Anasept saturated gauze. Thesaturated gauze was kept in place for 50 minutes, after which the plateswere collected and placed in an incubator for 18 hours at 37 C. Severallarge E. coli colonies grew on the surface opposite the hole on whichthe gauze was placed.

A second negative control study was performed with a commercial productthat employs a silver ion dressing, Allevyn. The Allevyn pad was placedon the surface of the gel facing the hole, as with the otherexperiments. The pad was applied according to the manufacturerinstructions. The Allevyn pad was kept in place for 50 minutes, afterwhich the plates were collected and placed in an incubator for 18 hoursat 37 C. The part of the gel facing the hole was completely covered withE. coli growth.

A third negative control study was performed with a commercial productthat employs galvanic decomposition of Zn and Ag electrodes, Procellera.The process here is driven by the difference in electrochemicalpotential of Ag and Zn, and a galvanic, self powered, electrolyticreaction. The Procellera pad was placed on the surface of the gel facingthe hole, as with the other experiments. The Procellera pad was appliedaccording to the manufacturer instructions. The Procellera pad was keptin place for 50 minutes, after which the plates were collected andplaced in an incubator for 18 hours at 37 C. The part of the gel facingthe hole was completely covered with E. coli growth.

The above experiments demonstrate the function of the electrolytic padand the advantage of this design over other sterilization configurationsand systems. It is evident that while the electrolysis pad was able tosterilize antibiotic resistant E. coli at a penetration of 5 mm from theapplied surface, the three negative controls tested, using themanufacturer instructions, were unable to effectively destroy themicroorganisms at a depth of 5 mm from the placement of the pads. Thisresult illustrates a major problem with the current treatment of woundinfections. It is evident that the current methods may not sterilizebacterial infection in the wound depth. Sterilization on the woundsurface—without penetrating the depth leaves open a possible source ofcontamination. The electrolysis technology may have the ability tosterilize deep into tissue, which could be particularly beneficial fordeep infections.

Example III

For a third non-limiting example, FIG. 10 illustrates a precisionelectrolysis pad 900 in accordance with an embodiment of the invention.The precision electrolysis pad may include all the elements in the samedevice. The precision electrolysis pad 900 may be provided in acontainer that is sealed and keeps the precision electrolysis pad 900sterile until opened for use. The container may be a vacuum sealed bagor other suitable container.

FIG. 10 is a view of the pad 900 from the side that may come intocontact with a wound. The two-electrode unit 905, similar to electrode400 in FIG. 4, is shown with the anode surface visible, the anodesurface may be similar to anode 410 in FIG. 4. All the components are onplane 910, embedded between two gel cylinders 915, 920. The gelcylinders 915, 920 may be made of agar gel or a hydrogel or any type ofmaterial that includes a saline solution and a pH buffer. The pH buffermay maintain a pH of between 2 and 6, preferably between 3 and 5,preferably 4. The gel may be 1.5 grams UltraPure Agarose (Invitrogen CatNo. 155510-027) dissolved in 100 ml of distilled water. To maintain a pHof −4, 590 ml of 1 Molar Citric Acid and 410 ml of Sodium Citrat may beused. Nine grams of NaCl were mixed into the solution to maintainsalinity. The outer dimension of each gel cylinder 915, 920 may be 2inches (53 mm) and the thickness may be 0.23 inches (6 mm).

The electronic components of the device may be assembled on a solidsurface 925. The solid surface 925 may be connected to the electrodes905 through electrical connections 930. A programmable microprocessor935 may turn on and off the electric current may be mounted to the solidsurface 925. The programmable microprocessor 935 may be a Bluetoothdevice that may be controlled from the exterior or a programmable chipor a simple on/off switch. In some embodiments, precision electrolysiselectrodes 905 may be a separate unit or an integrated unit as shown inFIG. 9. The power supplied to the electrodes may come from a stationarypower source or from a portable power source that may also be anotherpad connected to the electrodes 905 by an electric wire. To verify thatthe unit is operational an LED 940 may be run in parallel with theconnections 930. The power supply may be a battery. A battery (notshown) may be mounted to the opposite side of the solid surface 925. Thebattery may be a 3 Volt Lithium battery (Cr2032).

Example IV

The precision electrolysis concept may be implemented with other designsas well. The electrolytic process may be performed at the treatment siteand precision may be accomplished through placement of the electrodes atthe desired location, control over the pH environment, and activecontrol of the passage of current to generate the desired electrolysisproducts at the site.

In a fourth non-limiting example, a Petri dish was filled with aphysiological solution based agar gel with Kanamycin. To contaminate thesurface, an antibiotic resistant E. coli strain (ATCC Product No. 55244)was used, which was spread evenly on the agar gel. The sterilization wasperformed using a physiological saline gel pad with a pH of 4 designedcomposition similar to that in the previous experiments. However, herethe electrodes were two 0.7 mm diameter cylindrical electrodes made ofcarbon inserted vertical into the pad and not along the pad aspreviously described. The gel pad sterilization was activated with inputfrom a constant voltage power supply connected to the two electrodes

First the gel pad was applied on a contaminated surface of the Petridish for one minute without activating the electrodes. The pad was thenremoved and transferred the dish to an incubator for 36 hours inconditions most amenable for bacteria growth, at 37 C. The dish was thenremoved. In the second experiment the gel pad was applied as in thefirst experiment, but the gel was activated at specific predeterminedareas with two carbon electrodes, for a one minute activation of 20 V.The gel pad was then removed and the samples placed in the incubator for36 hours.

The gel pad was infused with a pH sensitive dye. The activated area wasshown through a change of color in the pad, as a function of the changein pH. A yellowish original color of the pad indicated a pH of 4. Whenelectrolysis occurred, the color of the activated part of the padchanged, according to the change in pH. This aspect of the gel pad mayallow the users to know immediately if the electrolysis activation issuccessful or not and the site of activation.

After the one minute activation the gel pad was removed and the Petridish incubated for 36 hours. After 36 hours the bacteria grew wellacross the entire petri dish. However, at areas in which gel pad wasactivated there was no spread of bacteria. This study may illustrate thefeasibility of and the characteristics of a precision electrolysisactive and controlled sterilization gel pad. It illustrates differentdesigns may be possible to accomplish the desired precisionelectrolysis.

The examples provided are for explanatory purposes only and should notbe considered to limit the scope of the disclosure.

The electrolysis apparatuses, devices, and systems described above andillustrated in FIGS. 1-9 may be used alone or in combination with othertherapies. For example, precision electrolysis may be performed inconjunction with thermal ablation in some applications. In someapplications, cells targeted for ablation may be permeablized before,after, or during electrolysis. Examples of devices, pads andpermeabilizing techniques are described in co-pending PCT ApplicationSerial No. PCT/US2014/065794, filed Nov. 14, 2014, entitled “METHODS,SYSTEMS, AND APPARATUSES FOR TISSUE ABLATION USING ELECTROLYSIS ANDPERMEABILIZATION,” which application is incorporated by reference hereinin its entirety for any purpose.

The cells may be sonoporated, electroporated, or chemicallypermeablized. In the case of electroporation, the same electrodes usedfor electrolysis may also be used for electroporation in someembodiments. In some embodiments, the electrodes for electroporation andelectrolysis are separate. The permeabilization of the cells mayincrease the diffusion of electrolysis products into the cells. Thecombination of therapies may increase the effectiveness of theelectrolysis.

It is to be appreciated that any one of the above embodiments orprocesses may be combined with one or more other embodiments and/orprocesses or be separated and/or performed amongst separate devices ordevice portions in accordance with the present systems, devices andmethods.

Finally, the above-discussion is intended to be merely illustrative ofthe present devices, apparatuses, systems, and methods and should not beconstrued as limiting the appended claims to any particular embodimentor group of embodiments. Thus, while the present disclosure has beendescribed in particular detail with reference to exemplary embodiments,it should also be appreciated that numerous modifications andalternative embodiments may be devised by those having ordinary skill inthe art without departing from the broader and intended spirit and scopeof the present disclosure as set forth in the claims that follow.Accordingly, the specification and drawings are to be regarded in anillustrative manner and are not intended to limit the scope of theappended claims.

What is claimed is:
 1. A method for delivering electrolysis products toa site, the method comprising: using a controller, generating anelectrical signal indicative of a timing and dose of the electrolysisproducts; and providing the electrical signal to a device proximate thesite, wherein the device is configured to generate the electrolysisproducts proximate the site responsive to the electrical signal.
 2. Themethod of claim 1, wherein the device comprises at least one electrodeand an aqueous matrix, wherein the electrolysis products are generatedin the aqueous matrix responsive to the electrical signal applying acurrent through the aqueous matrix.
 3. The method of claim 2, furthercomprising delivering a drug to the site, wherein the drug is includedwith the aqueous matrix.
 4. The method of claim 1, wherein the devicecomprises a pad, and wherein the method further comprises applying thepad to the site.
 5. The method of claim 1, wherein the device comprisesa pad, and wherein the method further comprises implanting the padproximate the site.
 6. The method of claim 1, wherein the devicecomprises one of a surface pad, luminal catheter, or a needle.
 7. Themethod of claim 1, wherein using the controller comprises accessing amemory storing electrical signal patterns suitable for particular dosesand depths of electrolysis product delivery.
 8. The method of claim 1,wherein the site comprises a bed sore, a diabetic ulcer, a burn, acne, atumor, an abdominal surface, a nerve, a blood vessel surface, anintestinal surface, an esophageal surface, a urethra surface, a bladdersurface, or a combination thereof.
 9. A method for deliveringelectrolysis products to a site, the method comprising: passing acurrent through an aqueous matrix, wherein the aqueous matrix isconfigured to produce electrolysis products responsive to the current;and modulating an amount of the electrolysis products produced by theaqueous matrix by changing at least one of a magnitude or a duration ofthe current.
 10. The method of claim 9, further comprising generatingthe current by applying an electrical signal to at least one electrode.11. The method of claim 10, wherein the electrical signal is a pulsedelectrical signal comprising one or more pulses.
 12. The method of claim9, further comprising controlling a direction of flow of ions of theelectrolysis by performing iontophoresis, electro osmosis,electrophoresis, or a combination thereof.
 13. The method of claim 9,further comprising removing depleted electrolysis products, ablatedmaterials, or a combination thereof from the site.
 14. The method ofclaim 13, wherein the removing comprises applying a negative pressure tothe site.
 15. The method of claim 13, wherein the removing is performedby a lumen of a catheter.
 16. The method of claim 9, wherein changing atleast one of the magnitude or the duration of the current comprisesturning the current on and off.
 17. The method of claim 9, furthercomprising measuring a pH of the site.
 18. The method of claim 17,wherein the changing at least one of the magnitude or the duration ofthe current is performed responsive the pH measured.
 19. The method ofclaim 9, wherein the current comprises a direct current.
 20. The methodof claim 9, further comprising delivering the aqueous matrix to the siteby injection, implantation, or a combination thereof.